Kornimate/medical-research-clean huggingface dataset:
accelerated treatment of endocarditis

Conditions: Infectious Endocarditis

Summary: existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two types of intravenously administered antibiotics. the long hospitalization increases several risks for the patient, including mental strain and increased loss of function. furthermore, it poses a significant burden on health systems. current guidelines fail to use available data collected from patients (echo, temperature, crp, leukocytes, procalcitonin etc.) to determine duration of treatment. a strategy including these data in treatment algorithms ensures an individualized treatment, targeting the patient's course and response to treatment. thus, the purpose of this open-label, prospective, non-inferiority, rct study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 750 patients, approx. 200 patients with each type of bacteria (streptococci; enterococcus faecalis; staphylococcus aureus). interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.


Eligibility criteria:
inclusion criteria: 1. patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised duke criteria. 2. the patient may be included \<14 days after beginning of relevant antibiotic treatment. 3. left-sided endocarditis with one of the following microorganisms: streptococci; enterococcus faecalis; staphylococcus aureus. 4. patients ≥ 18 years. exclusion criteria: 1. known / suspected immunocompetence (hiv, chemotherapy, prednisolone treatment (\> 20 mg / day)). 2. incapability to give informed consent for participation. 3. relapse endocarditis (endocarditis with the same bacteria within six months).
stem cell research on subjects at genetic high risk for schizophrenia

Conditions: Genetic High Risk for Schizophrenia

Summary: this study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells.


Eligibility criteria:
inclusion criteria: \[subjects at genetic high risk for schizophrenia\] * healthy without any axis i mental disorder * is a monozygotic twin of a patient with schizophrenia or has at least two family members of schizophrenia in the pedigree, including at least one 1st-degree family member \[healthy control\] * healthy without any axis i mental disorder * no family members of schizophrenia in the pedigree to the 3rd degree exclusion criteria: * significant neurological or medical illness * psychotic symptoms * substance abuse * suicidal risk * blindness or hearing loss * taking aspirin, warfarin or hormonal agents * pregnancy or lactation * susceptibility for keloid formation * allergy to lidocaine * history of significant head trauma or loss of consciousness * mental retardation

Keywords: schizophrenia stem cells neurons genetic hish risk for schizophrenia
pre-operative cerebral oxygenation in neonates with congenital heart disease

Conditions: Heart Defects, Congenital

Summary: congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. the causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. they relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. the importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. in this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.


Eligibility criteria:
inclusion criteria: * neonates with admission on neonatal intensive care unit with congenital heart disease. exclusion criteria: * no informed consent. (for the long term neurodevelopmental fu) * no cerebral oxygen saturation in the first 3 day's of life * gestational age \< 37 weeks

Keywords: heart defects, congenital patient monitoring infant, newborn physiology
determination of catheter contact by evaluation of microelectrode near-field signals

Conditions: Cardiac Catheter Ablation; Atrial Flutter; Cardiac Arrhythmias

Summary: successful radio frequency (rf) cardiac catheter ablation requires the creation of lesions by delivering energy while maintaining adequate catheter contact with the endocardium. unfortunately, it is difficult to identify contact intraoperatively as a typical rf ablation catheter lacks clear indications of contact. we propose to use the boston scientific intellatip mifi catheter to explore whether characteristics of the electrograms produced by the mini-electrodes on the ablation tip could help confirm tissue contact. using an ultrasound catheter to define instances of clear contact and non-contact, we will determine whether the micro-electrodes produce sufficient information to confirm catheter contact. we propose that the mifi catheter produces sufficient signal characteristics that can be used as an effective surrogate for adequate tissue contact.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of typical atrial flutter * subject is clinically indicated for right sided atrial flutter ablation * patient is willing and able to understand and sign the informed consent document * patient is over 18 years of age * patient is willing and able to comply with the study protocol exclusion criteria: * patient has one of the following cardiac comorbidities: hypertrophic cardiomyopathy, structural heart disease, congestive heart failure * patient has history of the following arrhythmias: ventricular tachycardia, ventricular fibrillation, wolff-parkinson-white syndrome * patient has a contraindication to right atrium ablation, including but not limited to: right atrial thrombus, active systemic infection, or a coagulopathy.
progesterone in patients with placenta previa

Conditions: Placenta Previa

Summary: this study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.

eligible women who consent to participate in the study are randomly allocated into one of the two study groups. women who are allocated to the study group will receive vaginal progesterone 400 mg \[prontogest® vaginal pessaries 400, marcyrl, cairo, egypt\], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.

Eligibility criteria:
inclusion criteria: 1. gestational age 26-28 weeks of gestation. 2. definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan. exclusion criteria: 1. multiple pregnancy. 2. women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (pprom). 3. severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. 4. women who have been maintained on progestin therapy since early pregnancy for whatever reason.
synergistic effect of vedolizumab and pentoxifylline

Conditions: Crohn Disease

Summary: the purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * patients with active crohn's disease (cd) defined by blood lab values, stool markers, abnormal mr enterography imaging, or colonoscopic findings * patients who are good candidates to start standard dosing of vedolizumab * patients who have not used an off-label or investigational drug for cd in the 8 weeks prior to screening * patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-tnf exposure and 8 weeks if there is a history of exposure to natalizumab * oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening * oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening * patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab * rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion exclusion criteria: * contraindications or history of allergy to ptx * known interaction of ptx with patient's current medications * use of an off-label or investigational drug for cd in the 8 weeks prior to first vdz infusion * pregnancy * gfr \<30 at any time in the 6 months prior to first infusion of vdz * documented cirrhosis * age \ 80 years old * contraindication to colonoscopy at 24 week study time-point
stanford center for back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of the stanford center for back pain is to investigate and characterize the mechanisms of four treatments for chronic low back pain. these interventions (research treatment) include real-time fmri neurofeedback, mindfulness based stress reduction, cognitive behavioral therapy, and acupuncture treatment. the investigators plan to characterize both mechanisms of treatment effects and efficacy.

the stanford center for back pain establishes a collaborative, multidisciplinary research program to investigate cam interventions for the treatment of chronic low back pain (clbp). the investigators' overall goal is to characterize the shared and distinct mechanisms of four cam interventions and translate the investigators' findings to tailored and effective treatments for clbp. clbp is a highly prevalent and difficult-to-treat condition for which many patients seek cam therapies. basic science has revealed that abnormalities in central pain modulatory and emotion regulatory systems play a crucial role in clbp. what is not clear is how cam therapies alter the functioning of the brain systems involved in chronic pain. the stanford center for back pain aims to fill this gap by conducting 3 projects, each aiming at elucidating mechanisms underlying different cam therapies for clbp. project 1 will focus on a promising novel alternative therapy for clbp real-time fmri neurofeedback which trains patients to control specific neural processes that lead to improvements in pain. project 2 will characterize the pain modulatory and emotion regulatory effects of mindfulness based stress reduction and cognitive behavioral therapy for clbp. project 3 will characterize psychophysical and neuroimaging based neural mechanisms underlying verum and placebo acupuncture. the stanford center for back pain will provide optimal collaboration and synergy within a multidisciplinary framework to identify mechanisms of cam therapies for clbp so that they can eventually translate them into enhance clinical care of clbp.

Eligibility criteria:
inclusion criteria: * english fluency * chronic low back pain as defined by nih task-force or healthy controls exclusion criteria: * mri contraindications * pregnant or planning to become pregnant * medical conditions that would interfere with study procedures, at the discretion of the study team * neurologic disorder, history of seizures, stroke, or brain abnormalities, which would interfere with brain integrity, at the discretion of the study team. * mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. * other project specific criteria may apply.
use of sterile hemaclear tourniquet below calf versus pneumatic tourniquet at the thigh for ankle and foot surgery

Conditions: Foot Fracture; Ankle Fractures; Ankle Injuries; Foot Injuries and Disorders

Summary: this is a randomized controlled trial evaluating the effects of the use of sterile hemaclear tourniquet below calf versus pneumatic tourniquet at the thigh for ankle and foot surgery the trial will randomize 60 patients into an experimental group with hemaclear or active comparator group with pneumatic tourniquet. the outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet


Eligibility criteria:
inclusion criteria: * ankle and foot surgery exclusion criteria: * infection * tumors * open fracture * burns * varicose veins * isquemia

Keywords: foot fracture ankle fractures ankle injuries orthopaedic devices associated with misadventures foot injuries and disorders
maintenance zd1839 (iressa®) following completion of front line, platinum-based, double chemotherapy in subjects with advanced or metastatic non-small cell lung cancer

Conditions: Non-Small-Cell Lung Carcinoma

Summary: in this phase iiib, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic non-small cell lung cancer (nsclc) (stage iiib {t4-pleural effusion} and iv) who have sd or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either zd1839 or placebo.


Eligibility criteria:
inclusion criteria: * must sign informed consent * females and males aged 18 years and over. * confirmed stage iiib (t4-pleural effusion) and iv nsclc. * either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy. * no prior egfr therapy * no newly diagnosed intracerebral metastases while receiving or after completing chemotherapy * at least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy * must be completely healed from previous major oncologic surgery * life expectancy of ≥ 8 weeks. exclusion criteria: * known severe hypersensitivity to zd1839 or any of the excipients of these products. * any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. * any unresolved chronic toxicity greater than common toxicity criteria (ctc) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia. * evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. * pregnancy or breast feeding (women of child bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy. * treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment. * signs of neurological symptoms consistent with new onset spinal cord compression or cns metastases. * treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to inclusion criterion -). exception: palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy. * males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.
ease of use of new blood glucose meter with in-built insulin calculator at home study

Conditions: Diabetes Mellitus

Summary: the aim of this study is to evaluate user preference and ease of use of the freestyle insulinx system, compared to current methodology, when used at home by subjects with diabetes. subjects will also be comparing the ease of use of the freestyle insulinx system with comparator meters.


Eligibility criteria:
inclusion criteria: * subject with type 1 or 2 diabetes on a bolus regime (u100 insulin), one or more bolus injections per day for at least 6 months; * age 18 yrs and above; * regularly testing smbg 3 or more times per day; * willingness to test at least 4 times per day. exclusion criteria: * know to require a bolus injection of more than 50u in a single dose; * has previously used either the insulinx or assigned comparison meter; * participated in structured diabetes management training in the last 6 months * is currently on an insulin pump; * has concomitant disease that, in the investigator's opinion, may compromise patient safety; * is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management; * female subject who is pregnant or planning to become pregnant during the course of the study.

Keywords: diabetes smbg insulin calculator
exercise periodization and older adults

Conditions: Aging; Physical Activity; Sarcopenia; Cognitive Decline; Blood Pressure; Physical Disability

Summary: the present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (np) and daily undulating periodization (dup) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. methods: forty-two older women were randomized allocated into one of the three experimental groups: np, dup, and control group (cg). evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. the exercise groups performed the program of exercise twice a week over 22 weeks. in np, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. however, in dup, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.


Eligibility criteria:
inclusion criteria: * aged ≥60 years; * female; * not having been part of a systematic program of physical exercises in the last 6 months; * meem score \>19 points; * kihon checklist score \>10 points; * capacity to perform the basic and instrumental activities of daily living according to katz and pfeffer indexes; * self-reported good memory; * complete all measurements. exclusion criteria: * changes on antihypertensive medication in the past 6 months prior to inclusion in the study; * cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease) * metabolic disease (i.e., diabetes mellitus type i or ii), pulmonary disease (i.e., emphysema) * neurological and/or psychiatric disease (i.e., parkinson's or alzheimer's disease) * skeletal muscle disorders * comorbidities associated with greater risk of falls * recent history of smoking or alcohol abuse * hormone replacement therapy and/or psychotropic drugs.

Keywords: older adults physical function muscle mass short-term memory executive function blood pressure resistance training exercise training periodization
caloric restriction and body weight in adults

Conditions: Overweight

Summary: the purpose of this study is to determine the role of 1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction. 2. caloric restriction on biomarkers of inflammation and oxidative stress


Eligibility criteria:
inclusion criteria: * 18 -65 years old * healthy exclusion criteria: * body weight more than 300 lbs (body composition measurement instrument limit) diabetes * heart disease

Keywords: dietary calcium weight loss
treatment of bile acid malabsorption with liraglutide

Conditions: Bile Acid Malabsorption

Summary: comparing the effect of liraglutide on bile acid malabsorption, with colesevelam

the overall objective of the present study is to provide proof of concept that treatment with the glp-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e. response to treatment) and safe (as assessed by adverse effects) in the management of bam and that it improves bile acid reabsorption (as assessed by sehcat) in these patients.

Eligibility criteria:
inclusion criteria: * • caucasian ethnicity * sehcat-verified moderate (5-10% bile acid retention after 7 days) or severe bam (\<5% retention) * normal haemoglobin (for men 8.3-10.5 mmol/l; for women 7.3-9.5 mmol/l) * age above 18 years and below 75 years * informed and written consent * bmi \>18,5 kg/m2 and \<40 kg/m2 * glycated haemoglobin (hba1c) \<48 mmol/mol exclusion criteria: * • history of or present hepatobiliary disorder (except for non-alcoholic steatotic liver disease) and/or alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>3 times upper limit of normal) or history of hepatobiliary disorder * gastrointestinal disease (except for bam), previous intestinal resection or any major intra-abdomial surgery * diabetes mellitus * nephropathy with egfr \< 60 ml/min/1.73m2 * treatment with medicine that cannot be paused for 12 hours * hypothyroidism or hyperthyroidism, if not well regulated. * treatment with oral anticoagulants * active or recent malignant disease * any treatment or condition requiring acute or sub-acute medical or surgical intervention * females of child-bearing potential who is pregnant (tested before entering the study), breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes intrauterine device (iud), birth control pills, sexual abstinence or living in a relationship with a sterile partner. * known or suspected hypersensitivity to trial products or related products * any condition considered incompatible with participation by the investigators
open label extension study in patients with idiopathic pulmonary fibrosis who completed protocol ac-052-321/ build 3 / nct00391443

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this open-label extension study in patients with idiopathic pulmonary fibrosis who completed protocol ac-052-321 / build 3 (nct00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (ipf).


Eligibility criteria:
inclusion criteria: patients should have completed all the assessments from the build 3 (nct00391443) end of study (eos) visit. * signed informed consent prior to initiation of any study-related procedures. * women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination. exclusion criteria: * any major violation of protocol ac-052-321 / build 3 (nct00391443). * pregnancy or breast-feeding. * ast and/or alt \> 3 times the upper limit of the normal range. * any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. * known hypersensitivity to bosentan or any of the excipients.

Keywords: actelion idiopathic pulmonary fibrosis bosentan tracleer interstitial lung disease build 3 (nct00391443)